Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect
This trial has been completed.
|Condition||coronary artery disease|
|Sponsor||Associations for Establishment of Evidence in Interventions|
|Start date||October 2013|
|End date||November 2015|
|Trial size||421 participants|
|Trial identifier||NCT02002910, J-DEFINE|
To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis.
To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.
time frame: 1 year after the procedure
time frame: baseline pocedure
Incidence of major adverse cardiac and cerebrovascular events(MACCE)
time frame: 1year after the pocedure
time frame: baseline pocedure
evaluation of variance
time frame: beseline procedure
All participants at least 20 years old.
- Age>=20 years old.
- Patient who can understand informed consent of the clinical study and signed the consent.
- Patient who is adaptable to CAG and/or coronary revascularization
- Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.
- Patient with known contraindications to Adenosine Triphosphate(ATP) and/or papaverine hydrochloride
- Target vessel diameter<=2.0mm
- Lesion with Chronic Total Occlusion(CTO) (registration allowed if other branch has stenosis more than 50% in visual judgment)
- Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block.
- Acute Myocardial Infarction(AMI) patient
- Patient who is disqualified for FFR and coronary revascularization by the investigator.
- Lesion is disqualified for Percutaneous Coronary Intervention(PCI) by the investigator.
- Patient who has critical valvular disease of heart. (moderate or severe Aortic valve stenosis(AS)/Aortic Regurgitation(AR)/Mitral Stenosis(MS)/Mitral Regurgitation(MR)）
- Patient with a prior Coronary Artery Bypass Graft(CABG) on target vessel.
- Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl)
- Patient on hemodialysis.
- Body weight>=200kg
- Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP＜90mmHg)
- Patient who expects to live less than 2 years at the registration
- Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy.
- Patient who is poor compliance with drug treatment.
- Patient who is allergic to contrast agent.
- Left Ventricular Ejection Fraction(LVEF)>=30%
- Patient who has the history of PCI with Drug-Eluting Stent(DES) in recent 3 months before registration.
- Patient who has the history of PCI with Bare Metal Stent(BMS) or Plain Old Balloon Atherectomy(POBA) in recent 1 year before registration.
- Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI.
- Patients with inadequacy to join this clinical study.
- Patient who has been enrolled any other clinical study.
|Official title||Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect|
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